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This study aims to evaluate Effectiveness of Investigational Device, Lunit INSIGHT MMG, in the assistance of Detection and Diagnosis of Breast Cancer during Screening Mammography Interpretation.
The Lunit INSIGHT MMG is developed as a computer-assisted detection/diagnosis device based on deep learning technology. In this pivotal study, effectiveness of the investigational device, Lunit INSIGHT MMG, was examined by comparing the reading panelist's interpretation ability between CAD assisted and unassisted during screening mammography interpretation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cancer |
|
| |
| Non-cancer | Has a suspicious lesion for breast cancer in screening mammograms and confirmed as a cancer (malignant) through the follow-up biopsy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mammography | Radiation | FFDM (Full-Field Digital mammography) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient-level FBR (forced BI-RADS) area under the Receiver Operating Characteristic (ROC) curve | Patient-level FBR (forced BI-RADS) area under the Receiver Operating Characteristic (ROC) curve to measure the effectiveness of Investigational Device between CAD assited and unassisted environment | Through study completion, an average of 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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Screenign Mammography Population
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| Name | Affiliation | Role |
|---|---|---|
| Gregg Miller, MD | Atrius Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atrius Health | Boston | Massachusetts | 02215 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| D017437 |
| Skin and Connective Tissue Diseases |